Device recall
Z-2745-2018: G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674…
FDA device recall · Class II · Tosoh Bioscience Inc
Key facts
| Recall number (Z-number) | Z-2745-2018 |
|---|---|
| Recall event | 80257 |
| Product | G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in… |
| Product code | LCP |
| Recalling firm | Tosoh Bioscience Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 9, 2021 |
| 510(k) numbers | K100304 |
| FEI number | 3005529799 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database